Identity
- Trade Name
- SR Phonares II Ant. 6er OS62 A1 EUDAMEDSR Phonares II FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Ivostar / Gnathostar, Ivocryl, Resin Teeth / DCL / PE, Resin Teeth S PE / S DCL, SR Phonares II EUDAMEDSR Phonares II Ant. set of 6 US62 A1 FDA UDI
- Model / Reference
- 644824 EUDAMEDFDA UDI
- Description
- SR Phonares II Ant. set of 6 US62 A1 FDA UDI
Identifiers
- Catalog Number
- 644824 FDA UDI
- Primary DI / UDI-DI
- 07615208359749 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082APROS004VZ EUDAMED
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Resin artificial teeth
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI 17b931ac-905d-418d-8160-93abeb161dd5 34 fields · synced Jul 19, 2026
- EUDAMED 811e9cdb-5521-4a13-9b4f-b7133d193109 61 fields · synced Jun 19, 2026